Gynecologic Neoplasms Clinical Trial
Official title:
Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial
The purpose of this study is to determine whether it is safe to give a regular diet as the first postoperative meal in patients who underwent surgical treatment for clinically early-stage gynecologic cancer.
Paralytic ileus, a temporary inhibition of bowel motility, is believed to follow all
abdominal surgery. Surgeons have customarily withheld postoperative oral intake until the
return of bowel function as evidenced by a presence of bowel sound, a passing of
flatus/stool, and a feeling of being hungry. The major concern has been that early oral
intake would result in vomiting from severe paralytic ileus with subsequent aspiration
pneumonia, wound dehiscence, and anastomotic leakage. Recently, the practice of delayed
postoperative oral intake has been challenged by evidence from extensive gastrointestinal
physiologic studies that examine contractile activity of the intestine. These data have
suggested that the concept of postoperative ileus as paralysis of the entire bowel with
complete absence of any functional contractile activity is misleading. If postoperative
ileus takes place, it is usually transient and not significant clinically. Several possible
clinical benefits of early feeding after surgery exist that include better wound healing,
postoperative stress ulcer prevention, reduced sepsis, improved sense of well being, shorter
length of hospital stay, and cost saving. Currently, the practice of early administration of
liquid diet after surgery has become widely accepted. For early regular diet administration,
the proposed additional benefits would be lesser risk of aspiration, faster recovery of
intestinal motility, and better nutritional status. Patients who had surgery as a treatment
for gynecologic cancer deserve special attention in this regard as they generally have
higher risk of developing postoperative ileus due to extensive and/or multiple
intraabdominal surgical procedures including radical hysterectomy, pelvic lymph node
dissection, and surgical staging procedures. At the same time, this is the group of patients
that would benefit most from the aforementioned positive effects of early regular diet
feeding.
Comparisons: Regular versus liquid diet as the first postoperative meal on the first day
after surgery for clinically early-stage gynecologic cancer.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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